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| Descriptive Information Fields | |||||||||
| Brief Title † | CALERIE (PBRC, Baton Rouge) - Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy | ||||||||
| Official Title † | Metabolic Adaptations to Six Month Caloric Restriction | ||||||||
| Brief Summary | This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet improves biomarkers of aging and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are participating in the CALERIE trial represent a diversity of subject populations and interventional strategies. |
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| Detailed Description | This study tests whether chronic caloric restriction improves risk factors of longevity in humans as it is known to do in animals, by measuring a variety of factors dealing with metabolism and oxidative stress, through physical evaluations and laboratory tests. Participants will receive dietary counseling and free medical evaluations. In addition, each volunteer will be asked to do one of the following:
Three separate five-day inpatient stays are required. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Aging Cardiovascular Disease Diabetes Mellitus |
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| Intervention † | Behavioral: Caloric Restriction (CR) Behavioral: Exercise |
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| MEDLINE PMIDs | 16595757, 12936916, 8450723, 8658196, 11103847, 3283209 | ||||||||
| Links | CALERIE - PBRC website  CALERIE Coordinating Center |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 48 | ||||||||
| Start Date † | March 2002 | ||||||||
| Completion Date | August 2004 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 25 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00099151 | ||||||||
| Organization ID | AG0005 | ||||||||
| Secondary IDs †† | 5U01AG020478-02 | ||||||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||||||
| Verification Date | December 2004 | ||||||||
| First Received Date † | December 8, 2004 | ||||||||
| Last Updated Date | May 2, 2006 | ||||||||
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